Monday, 13 April 2020

Application of a Riboprinter® for Microbiological Control in Pharmaceuticals

There
is a regulatory expectation for use of genotypic identification methods for
certain types of isolates from pharmaceutical manufacturing events (such as
media fill or sterility test failures). This is especially so if an attempt is
to be made to invalidate a test. An example of such a system, which provides
genotypic identification and the ability to match organisms based on genetic
similarity, is the RiboPrinter. The RiboPrinter technology has an additional
advantage to aid pharmaceutical microbiologists – it can match organisms, to
show genetic level similarity and this is something that can proof invaluable
with root cause analysis.

The
commercialization of the technology led to the DuPont™ RiboPrinter® System,
which automates restriction fragment length polymorphism (RFLP) analysis and
targets the rRNA-coding region of the bacterial genome.

This
article outlines the Riboprinting technology and discusses some applications of
the approach, which can assist within investigations within the pharmaceutical
context.